Morph AccessPro Steerable Introducer MAP690

GUDID 00866749000257

BIOCARDIA, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID00866749000257
NIH Device Record Keyeb3d16f5-b887-466c-a3b7-54f35add4547
Commercial Distribution StatusIn Commercial Distribution
Brand NameMorph AccessPro Steerable Introducer
Version Model NumberMAP690
Catalog NumberMAP690
Company DUNS122370146
Company NameBIOCARDIA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com
Phone6502260120
Emailinfo@biocardia.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866749000257 [Primary]

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

[00866749000257]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2016-10-10

On-Brand Devices [Morph AccessPro Steerable Introducer]

00866749000257MAP690
00866749000240MAP645
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